CLEVELAND (Legal Newsline) - The Drug Enforcement Agency must turn over records of audits that Rite Aid and other pharmacies facing litigation say will show they complied with the government’s requirements to detect and intercept suspicious opioid orders.
The U.S. Department of Justice has fought the discovery requests for more than a year, arguing they are overly burdensome, would reveal investigative methods and have “minimal relevance” to the pharmacies’ defense. In an order dated April 10, Special Master David R. Cohen, who is in charge of settling disputes over pretrial evidence-gathering in the opioid multidistrict litigation, disagreed.
“There is little question that the requested documents and testimony are highly germane,” Cohen wrote. One memo immediately after an unannounced July 2012 audit of a Rite Aid distribution center concluded that two DEA inspectors were “very impressed and pleased to see that Rite Aid demonstrates its due diligence by having an excellent excessive order monitoring system.”
The special master ordered the government to turn over audit records for five other pharmacy defendants facing bellwether trials this fall, including Walmart, Walgreens and CVS. He also ordered the DOJ to make available for a 3.5 hour deposition Donald Tush, a DEA investigator who conducted some of the audits.
The special master’s order could provide evidence to undercut the central claim in lawsuits against pharmacies and distributors - that they failed to maintain adequate systems for detecting and stopping suspicious orders. The DEA dramatically increased production quotas for oxycodone and other heavily abused opioids in the 2000s while refusing to provide standards for distributors on how to define suspicious orders.
Those companies - now facing thousands of lawsuits by states, cities and counties nationwide - say they are being sued largely for fulfilling legitimate prescriptions by licensed physicians.
According to some estimates by experts hired by the bellwether plaintiffs, Cuyahoga and Summit counties in Ohio, more than half and even up to 80% of the prescriptions written in those counties could be considered “suspicious.”
“The adequacy of Rite Aid’s suspicious order monitoring system (SOMS) is at the very center of the issues to be decided during the upcoming trial in Track One-B, and DEA’s assessment of the adequacy of Rite Aid’s SOMS could not be more relevant,” Cohen wrote.
In his order, Special Master Cohen expressed frustration with some of the government’s tactics, which included refusing to honor subpoenas because they were served on DEA officials instead of the agency itself. He also chastised the government for arguing its audits only addressed “physical security and record-keeping” at the pharmacy distribution centers, since memos clearly refer to suspicious ordering systems.
And the government argued it shouldn’t be forced to turn over the audit records because they might reveal confidential enforcement techniques.
Cohen called the claim “clearly hyperbolic,” since distributors already know by now that unannounced audits begin at 9 a.m., last eight hours, and focus on opioids.
The dispute over DEA records is the latest in a series of pretrial fights between defendants and the government, and defendants and the court itself. Some defendants have asked U.S. District Judge Dan Polster, who is overseeing the MDL, to recuse himself. They also have an appeal pending in the U.S. Court of Appeals for the Sixth Circuit over Judge Polster’s order allowing an unprecedented “negotiation class” consisting of every city and county nationwide. Numerous states have joined the effort to have that order reversed.